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KMID : 0191120170320111807
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Journal of Korean Medical Science
2017 Volume.32 No. 11 p.1807 ~ p.1813
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Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study
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Choi Yoon-Jin
Lee Dong-Ho
Choi Myung-Gyu
Lee Sung-Joon
Kim Sung-Kook
Song Geun-Am
Rhee Poong-Lyul
Jung Hwoon-Yong
Kang Dae-Hwan
Lee Yong-Chan
Lee Si-Hyung
Choi Suck-Chei
Shim Ki-Nam
Seol Sang-Yong
Moon Jeong-Seop
Shin Yong-Woon
Kim Hyun-Soo
Lee Soo-Teik
Cho Jin-Woong
Choi Eun-Kwang
Lee Oh-Young
Jang Jin-Seok
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Abstract
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This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was ?0.4% (95% confidence interval, ?9.8% to 9.1%), which was above the non-inferiority margin of ?14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)
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KEYWORD
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Artemisia, Gastritis, Double-blind Study, Adverse Drug Event, Endoscopy
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